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Clinical Trials/NCT01622166
NCT01622166
Completed
Not Applicable

Art Therapy for Symptom Reduction in Acute Schizophrenia - a Randomised Controlled Trial (Kunsttherapie Zur Symptomreduktion Bei Akuter Schizophrenie - Eine Randomisierte Kontrollierte Pilotstudie)

Charite University, Berlin, Germany1 site in 1 country60 target enrollmentAugust 2011
ConditionsSchizophrenia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Schizophrenia
Sponsor
Charite University, Berlin, Germany
Enrollment
60
Locations
1
Primary Endpoint
Change in Positive and Negative Syndrome Scale (PANSS-) scores
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

Randomised, controlled, single-blinded pilot study to assess the efficacy of psychodynamic art therapy in a sample of hospitalized, (sub)acutely psychotic patients with a diagnosis of schizophrenia compared to a group of patients receiving treatment as usual.

*Main hypothesis: Art therapy has no impact on clinical symptoms and the course of remission compared to TAU.

*Exploratory hypotheses: Art therapy has no influence on quality of life, mentalizing function, self-efficacy and neuroleptic dosage compared to TAU.

Registry
clinicaltrials.gov
Start Date
August 2011
End Date
January 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Christiane Montag MD

Principal Investigator

Charite University, Berlin, Germany

Eligibility Criteria

Inclusion Criteria

  • diagnosis of schizophrenia according to DSM-IV-TR
  • age 18-64 yrs
  • sufficient German language competency
  • written informed consent

Exclusion Criteria

  • axis-I mental disorders other than schizophrenia
  • comorbid antisocial personality disorder, relevant substance abuse,
  • relevant severe somatic disease
  • acute suicidal tendencies or aggression
  • incapability to tolerate group settings

Outcomes

Primary Outcomes

Change in Positive and Negative Syndrome Scale (PANSS-) scores

Time Frame: weeks 0, 6, 12

assessment of change of schizophrenic positive, negative and general symptom scores

safety measures

Time Frame: weeks 0, 6, 12

number of participants with adverse events

Change in Calgary depression Scale (CDS-) scores

Time Frame: weeks 0, 6, 12

assessment of change of depressive symptoms in schizophrenic patients as reflected by CDS-scores

Study Sites (1)

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